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State of the DoD Pharmacy Benefit_ Process _ Implementation

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					             A Peek at the PEC:
 An Overview of Formulary Management at the
   Department of Defense (DoD) TRICARE
Management Activity (TMA) Pharmacoeconomic
                Center (PEC)




                LCDR Marisol Martinez, PharmD
                   Fort Sam Houston, TX
 DoD/TMA Pharmacoeconomic Center
    Promoting high quality, cost effective drug therapy throughout the Military Health System
 www.pec.ha.osd.mil
                                           Objectives

• Discuss the Department of Defense (DoD) TRICARE
  pharmacy benefit and the role and responsibility of the
  PEC in formulary management
• Discuss the lessons learned from the DoD P&T process
  for conducting drug class reviews to determine clinical
  and cost effectiveness
• Review the functions of the Pharmacoeconomic
  Outcomes Research Team (PORT) and the implications
  of formulary decisions on military treatment facilities
  (MTF)



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                                          Outline

•    TRICARE Pharmacy Benefit
•    Roles of the PEC
•    Process Timeline
•    Determining Clinical Effectiveness
•    Determining Cost Effectiveness
•    Functions of the PORT
•    Implications of P&T’s decisions
•    Conclusion
•    Questions



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                                            TRICARE
                         Pharmacy Benefit Background

•       Points of service
      –       MTF
      –       Retail
      –       Mail Order
•       Population – 9.7 million beneficiaries
      –       Active duty, retired Uniformed Service members, and
              family members
•       Expenditures – $7.5 billion dollars
•       Uniform Formulary Rule
      –       P&T Committee mandated by Congress


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                                  TRICARE Formulary



                                   Basic Core
                                   Formulary


                                   Uniform
                                  Formulary
     Non                            Extended
  Formulary                           Core
                                    Formulary




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                                       TRICARE
            Pharmacy Benefit – Points of Service
                                                                             FY09


                                                 30-day          %           Total
POS                Rxs       30-day Rxs*        Rxs (%)*       Dollars      Dollars

MTF        48,101,964        80,252,540            44%           19%       $1.43 B

Retail 71,414,850            73,753,775            40%           67%       $5.06 B

Mail
      10,454,703             30,148,634            16%           14%       $1.05 B
Order
                                     *Normalized based on 30-day supply of medications



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                                  The PEC Staff




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                           Responsibilities of the PEC

• Evaluate the clinical and cost effectiveness of
  drug therapy to support the DoD P&T Committee
  formulary decision-making process
• Implement and maintain the DoD pharmacy
  benefit
• Assess the outcomes of drug therapy to improve
  patient care and provide a feed-back loop for the
  DoD P&T Committee



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                                                  Process Timeline

                                              Drug Class
                        Implementation
                                               Selection




           TMA Director                       PEC completes Clinical and
            Decision                             Economic Analysis




                     Beneficiary                    Consult
                      Advisory                       with
                       Panel                        PORT
                                     DoD
                                     P&T
                                    Meeting

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                                      Drug Class Selection

• High expenditures across Military Health System
  (MHS)
      – “20/80 Rule”: 20% of the drugs comprise 80% of the
        expenditures
•   Market competition within a class
•   Expiration of existing DoD or DoD/VA contracts
•   Impending generic competition
•   Newly approved drug likely to impact existing
    class


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                                   Drug Class Selection

• November 2010 P&T meeting
   – Januvia and Onglyza
• Rationale
   –   Not previously reviewed                       JANUVIA


   –   Significant cost to the DoD
   –   Increased utilization                        JANUMET

   –   Safety concerns
   –   Clinical guidelines
                                                     ONGLYZA




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                                                  Process Timeline

                                              Drug Class
                        Implementation
                                               Selection




           TMA Director                       PEC completes Clinical and
            Decision                             Economic Analysis




                     Beneficiary                    Consult
                      Advisory                       with
                       Panel                        PORT
                                     DoD
                                     P&T
                                    Meeting

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                                   Clinical Analysis
                                   Review Process
• Team Approach

• Drug Class Review
   –    Key Questions
   –    Background
   –    Efficacy
   –    Safety
   –    Tolerability
   –    Other Factors

• Formal Presentation
   – Utilization and Spend
   – PEC Recommendations
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                               Clinical Analysis
                       Evidence Based Medicine
• Goal
  – Use the best quality evidence when determining differences
    within the drug class

             Meta-analyses and Systematic Reviews

                  Randomized Controlled Trials

                      Non-randomized Trials

                         Cohort and Case
                          Control Studies
                             Poster
                          Presentations

                              Reps
                                                                 14
                                           Clinical Analysis
                                   Evidence Based Medicine
• Januvia and Onglyza Evidence
    – No meta-analysis or systematic reviews
    – Relied on randomized controlled trials for
      efficacy and safety
    – Head-to-Head trial




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                                           Head-to-Head Trial
                                      Saxagliptin vs Sitagliptin
•   18 week, Phase 3b, MC, DB, non-inferiority trial
•   Saxagliptin 5mg OR Sitagliptin 100mg
•   Stable metformin doses (1500-3000mg/day)
•   Primary endpoint
    –  from baseline A1c
    – Non-inferiority concluded if upper limit of 2-sided 95% CI of the
      A1c difference between treatments was <0.3%
• Secondary endpoints
    – % of patients achieving A1c < 6.5% and 7%
    –  from baseline FPG, insulin, C-peptide, proinsulin, HOMA-2


    DoD/TMA Pharmacoeconomic Center                                                    16
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                                                  •Diabetes Metab Res Rev 2010;26;540-549.
                                   Saxagliptin vs Sitagliptin
                                                     Results
                                        SAXA + Met             SITA + Met
                                          N = 334               N = 343
Mean (SE) A1c at baseline (%)           7.68 (0.052)          7.69 (0.047)
Mean (SE) A1c at week 18 (%)            7.16 (0.052)          7.07 (0.051)
Adjusted change from baseline A1c
(%)
    Mean (SE)                           -0.52 (0.039)        -0.62 (0.038)
    Two-sided 95% CI                     -0.60, -0.45         -0.69, -0.54
Difference in adjusted change from
baseline A1c vs sitagliptin + met (%)
     Mean (SE)                          0.09 (0.055)                  -
     Two-sided 95% CI                    -0.01, 0.20                  -
SE = standard error




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                                                    •Diabetes Metab Res Rev 2010;26;540-549.
                                    Clinical Analysis
                                       Provider Input
• Developed by the clinical evaluation team
• Sent via email using web survey tool
• Questionnaire
   – Physicians
   – Pharmacists
   – Other healthcare providers
• Summarized responses presented to the P&T
  Committee
• Missing input from civilian network providers
• Januvia and Onglyza: Email Invites > 500,
  Responses 443
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•Survey: Non-Insulin Anti-Diabetic Agents: To what extent do you agree or disagree with this statement: "In order to treat the majority of y ...




              DoD/TMA Pharmacoeconomic Center                                                                                                      19
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                                   Economic Analysis
                           Relative Cost-Effectiveness
• Two broad types of economic analyses
    – Pharmacoeconomic Analysis
           • Evaluates the outcomes and costs of interventions
             designed to improve health
           • 4 types
    – Budget Impact Analysis (BIA)
           • Accounts for costs associated with a decision
           • Estimates the likely impact (use and cost) of a
             formulary decision over 2-3 years



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      Types of Pharmacoeconomic Analysis

• Cost-Minimization Analysis (CMA)
    – Treatments are equally effective
    – Cost is only factor
• Cost-Effectiveness Analysis (CEA)
    – Outcomes vary but can be expressed in a common unit
    – Combines clinical benefits with cost efficiency
• Cost-Utility Analysis (CUA)
    – Costs and consequences of different interventions in terms of the
      patient’s health-related quality of life and survival time
• Cost-Benefit Analysis (CBA)
    – Compares the net costs of a health care intervention with the
      benefits as a result of applying that intervention

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                                                                          CMA Results
               $3.00
                                                    Retail
               $2.50                                                  Retail             Retail
                                    Retail
               $2.00                                       $2.00
Cost ($)/Day




                                                                             $1.75
                                                                                                $1.55
               $1.50                                 MTF
                                                                       MTF
               $1.00                      $1.00                                           MTF

                                                  Weighted average cost for all 3 POS standardized to
               $0.50                              drug A market share (46% MTF; 30% RET; 24% MAIL)
                                    MTF

               $0.00
                                                   Drug B            Drug B             Drug B
                                     Drug A
                                                  (1 of 1 UF)      (1 of 2 UF)       (1 of 2 UF/BCF)

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                                          Economic Analysis
                                            Decision Criteria
                                         Rejection
                                  Cost   threshold

                     NO                              MAYBE
                                   Increase

                                                              Acceptance
                                                               threshold
                     Worse                           Better
                                                              Effect


                                   Decrease
              MAYBE                                   YES



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                                                  Process Timeline

                                              Drug Class
                        Implementation
                                               Selection




           TMA Director                       PEC completes Clinical and
            Decision                             Economic Analysis




                     Beneficiary                    Consult
                      Advisory                       with
                       Panel                        PORT
                                     DoD
                                     P&T
                                    Meeting

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          Pharmacy Outcomes Research Team
                                   (PORT)
• Co-located in DC and San Antonio
    –   3 pharmacists
    –   2 pharmacoeconomists
    –   Data analyst
    –   Technical writer
• Improve the outcomes of drug therapy and
  enhance the quality of the TRICARE pharmacy
  benefit
• Support the DoD P&T Committee and assess
  the effects of formulary changes on DoD
  beneficiaries


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                 “First-line Use”: New Antidiabetic Users
       No Antidiabetic Rxs Prior 12 Months, Combos w/ Parent Agents
                                             •X12
                                                                    Total unique
                        Jul 09 –   New users        Estimated new    utilizers/yr     % new
July 10                 Jun 10       Jul10            users/year    Jul09-Jun10       users
DPP-4                   No           495                5940           93,661            6
GLP-1                   antidiab      98                1176           23,053            5
                        etic Rx
TZD                                  460                5520           140,156           4
Insulin (any)                        1177              14,124          159,665           9
SU                                   1449              17,388          222,537           8
Metformin                            5959              71,508          423,224          17
                                    •New metformin users represent 17% of all metformin users
Other                                 60                720            16,513            4
antidiabetics
•Note: This method counts individuals who received an Rx for a given drug or drug
class during a given month (e.g., Jul10) but NOT during the previous 12-month
period (e.g., Jul 09 to Jun10); all POS

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                                         “First-Line” Use of DPP-4s

• 93,661 unique users Jul 09 – Jun 10
• Estimated new users per year (n)
   – No antidiabetics at all, last 12 months = 5940
   – No DPP-4 last 12 months = 35,364
   – No DPP-4, had Met or SU, last 12 months = 27,636
• ~22% of new DPP-4 users had no Met or SU last 12
  months
• Of these, about 1/3 (1788) had antidiabetics other than
  Met or SU prior to DPP-4s
• So, the percent of new DPP-4 users with no prior
  antidiabetic use is ~17%


                •DoD Pharmacy Outcomes
  DoD/TMA Pharmacoeconomic Center                                     27
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                Research Team
                                                  Process Timeline

                                              Drug Class
                        Implementation
                                               Selection




           TMA Director                       PEC completes Clinical and
            Decision                             Economic Analysis




                     Beneficiary                    Consult
                      Advisory                       with
                       Panel                        PORT
                                     DoD
                                     P&T
                                    Meeting

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                                      DoD P&T Meeting

•    Uniform Formulary placement
•    Basic Core Formulary (BCF) additions
•    Medical necessity criteria for NF drugs
•    Prior authorization requirements
•    Quantity limits
•    Minutes of each meeting include
     recommendation summaries and supporting
     documentation



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                                        DPP-4 Inhibitors
                             Relative Clinical Effectiveness

• DoD P&T Committee Recommendation on the
  Relative Clinical Effectiveness (vote)
   – Motion: The DoD P&T Committee agrees with the
     relative clinical effectiveness analysis of DPP-4s as
     presented




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                                           BCF Decision
                                    PEC Recommendation

• Recommendation
    – Januvia and Janumet BCF
• Justification
    – Budget impact analysis showed more cost effective
      when placed on the BCF
    – Questionnaire results showed preference for a BCF
      agent



  DoD/TMA Pharmacoeconomic Center    •BCF=Basic Core Formulary   31
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   Medical Necessity vs Prior Authorization
• Medical Necessity
   – Requirement when drugs are made Non-formulary
   – Five criteria to meet medical necessity
          • CI, ADR’s, Tx failure, stable patient and unacceptable risk if
            change to UF drug, no UF alternative
   – Retail/Mail Order: Fulfilling MN reduces co-pay from
     $22 (NF) to $9 (UF)
   – MTF: Fulfilling MN allows pt to receive NF drug at MTF
• Prior Authorization
   – Drug with PA can be in a UF-reviewed class (PDE-5s,
     biologics for RA), or class not previously reviewed
   – Assist with ensuring appropriate use

                                    •NF=Non-formulary
 DoD/TMA Pharmacoeconomic Center    •MTF=Military Treatment Facility         32
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                                    •UF=Uniform Formulary
                                              Step Therapy

• Automated Prior Authorization = Step Therapy
     – Applies to Retail Network/Mail Order, where computer
       can look back at patient’s profile
     – Requires use of preferred agent first, then can try
       others in the class that are UF
     – PPIs , BPH drugs, Insomnia
• Manual Prior Authorization
     – When automated PA fails
     – Physician initiates a call or fills out form



DoD/TMA Pharmacoeconomic Center                               33
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                                                 Step Therapy



                                  Automated
                                  review of
                                  patient profile.          Rx pays
                                  Has the patient       YES and is
                                  previously                dispensed
                                  received the
                                  preferred
                                  product?
Prescription   Pharmacy       PDTS checks patient
written        processes      profile                    NO
               prescription                                    Rx does not
                                                               pay


                  Prior Authorization required
                  Or, Patient must try the preferred product
                                                                             34
                                                  Process Timeline

                                              Drug Class
                        Implementation
                                               Selection




           TMA Director                       PEC completes Clinical and
            Decision                             Economic Analysis




                     Beneficiary                    Consult
                      Advisory                       with
                       Panel                        PORT
                                     DoD
                                     P&T
                                    Meeting

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        The Beneficiary Advisory Panel (BAP)
                             Washington DC
• Congress established
• Focus on implementation of UF decisions
    – Enhance transparency to beneficiaries
• Members
    –   Active duty family members
    –   Retirees and their family members
    –   2 clinical experts outside of the DoD
    –   Pharmacist from the US Family Health Plan
    –   Physicians or pharmacists from the TRICARE
        regional contractors

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                                              The BAP

• Concerns regarding Januvia and Onglyza
    – Does the Committee consider the mechanism of
      action when deciding where to place an agent?
    – Does a patient need to go through step therapy to use
      metformin in combination?
    – Can a patient get Janumet without trying a
      sulfonylurea or metformin first?




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                                                  Process Timeline

                                              Drug Class
                        Implementation
                                               Selection




           TMA Director                       PEC completes Clinical and
            Decision                             Economic Analysis




                     Beneficiary                    Consult
                      Advisory                       with
                       Panel                        PORT
                                     DoD
                                     P&T
                                    Meeting

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         TRICARE Management Activity (TMA)
                        Director Decision
                                   • Reviews comments and
                                     approves the P&T
                                     minutes
                                   • After the minutes are
                                     approved, the decisions
                                     may be made public
• Dr. Jonathan Woodson
• Assistant Secretary of
  Defense for Health Affairs
• Director, TMA



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        TRICARE Management Activity (TMA)
                         Signed Minutes




DoD/TMA Pharmacoeconomic Center             40
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                                  Process Timeline




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                                      Implementation

• 30, 60, 90, up to 180 day implementation
    – Based on level of effort and awareness necessary to
      make the change
• Several things happen
    –   Education
    –   Operations
    –   Prior Authorization edits-testing
    –   Formulary search tool and Epocrates
    –   Monitoring
• DPP-4 Inhibitors - 60 day implementation

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                                        Summary

• Review of the TRICARE formulary is important to
  help manage a $7.5 billion dollar pharmacy
  benefit
• Formulary management is accomplished through
  a thorough evaluation of efficacy, safety, and cost
• The PEC staff assists the DoD P&T Committee
  with recommendations that provide the greatest
  value to the Military Health System



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                                  Questions




DoD/TMA Pharmacoeconomic Center               44
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            A Peek at the PEC:
An Overview of Formulary Management at the
   TRICARE Management Activity (TMA)
     Pharmacoeconomic Center (PEC)




    LCDR Marisol Martinez, PharmD
 Email: marisol.martinez@amedd.army.mil
 DoD/TMA Pharmacoeconomic Center
    Promoting high quality, cost effective drug therapy throughout the Military Health System
 www.pec.ha.osd.mil

				
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